Neural Biomarkers of Electroconvulsive Therapy Response
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNorthwell Health
About this trial
In the proposed study, the investigators will utilize resting-state functional MRI (fMRI) and structural MRI-based electrical field modeling to study the effect of electroconvulsive therapy on human neural circuitry. Our study will recruit patients who are beginning treatment with bilateral electroconvulsive therapy (N=75). Our design will be longitudinal where patients will be followed up until their 8th week electroconvulsive therapy clinically. The primary measure of interest will be the slope of clinical change estimated with mixed effect modeling (see Approach). Secondary measures will be the cognitive performance change between baseline and the 8th week electroconvulsive therapy time point.
Eligibility criteria
Qualifiers
current positive symptoms rated ≥4 (moderate) on one or more of these BPRS 53 items: hallucinatory behavior, unusual thought content, suspiciousness, conceptual disorganization;
has failed at least one trial of treatment with antipsychotic drug, lasting 6 weeks in duration,
competent and willing to sign informed consent;
for women, negative pregnancy test and agreement to use a medically accepted birth control method; and
Disqualifiers
serious neurological or endocrine disorder;
any medical condition which requires treatment with a medication with psychotropic effects;
significant risk of suicidal or homicidal behavior;
cognitive (MMSE ≤ 23) or language limitations that would preclude subjects providing informed consent;
Trial design
Treatments tested in this trial
- clinical and neuropsychological testing
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
Northwell Health
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov